Senior Quality Assurance Specialist
On-siteRichland, Washington, United States
Job Summary
Serve as the primary quality contact for manufacturing-related nonconformance and CAPA activities, reviewing investigations for root-cause analysis and corrective actions. Maintain NC and CAPA records within the electronic quality management system while ensuring compliance with FDA 21 CFR, ISO 13485, and MDSAP standards. Track quality performance indicators, develop internal process audits, and support notified-body audits and FDA inspections as a subject-matter expert. Review validation protocols, calibration records, and equipment maintenance reports while monitoring process controls, supplier quality, and product conformity. Lead resolution of quality issues across manufacturing, operations, and support teams, providing quality-system training and developing improved compliance processes.
Required Qualifications
- Bachelor's degree in life sciences, engineering, or a related field, or an equivalent combination of education and experience
- At least eight years of quality assurance experience
- Experience within the medical device or pharmaceutical industry
- Working knowledge of FDA 21 CFR requirements, ISO 13485, and MDSAP
- Good Manufacturing Practices certification
- Experience managing nonconformance investigations and CAPA processes
- Strong knowledge of quality systems, manufacturing controls, and regulatory compliance
- Experience supporting internal audits, regulatory inspections, or notified-body audits
- Strong root-cause analysis, problem-solving, and process-improvement skills
- Excellent documentation, organization, and attention to detail
- Ability to interpret standard operating procedures and work instructions
- Strong written and verbal communication skills
- Ability to work effectively with cross-functional teams and manage multiple deadlines
- Proficiency with Microsoft Outlook, Word, Excel, and PowerPoint
- Ability to work a flexible schedule and travel as needed
- Ability to successfully complete required background and drug screenings
Desired Qualifications
- Experience working in a radiologically controlled environment is preferred
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